Inion OTPS BioRestore™ BRS-1601

GUDID M224BRS16019

Block 60x40x8 mm

Inion Oy

Synthetic bone graft

• Primary Device ID: M224BRS16019
• NIH Device Record Key: 96da0368-d5f2-454e-a7b7-10ee80eb409e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion OTPS BioRestore™
• Version Model Number: 1
• Catalog Number: BRS-1601
• Company DUNS: 367994657
• Company Name: Inion Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M224BRS16019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070784

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-02-07

On-Brand Devices [Inion OTPS BioRestore™]

• M224BRS16209: Cylinder 8x15 mm
• M224BRS16119: Morsels 1.5 cc
• M224BRS16109: Morsels 4.5 cc
• M224BRS16019: Block 60x40x8 mm
• M224BRS16009: Block 30 x 20 x 8 mm
• 06438408009617: Block 5 x 10 x 4 mm
• 06438408009600: Morsels 1.5 cc
• 06438408009594: Morsels 4.5 cc
• 06438408009068: Cylinder 8x15 mm
• 06438408009051: Block 60x40x8 mm
• 06438408007941: Block 30 x 20 x 8 mm